Banded Sleeve Gastrectomy Improves Weight Loss Compared to Non-banded Sleeve: Mid-term Results

University of Rome Tor Vergata

Status: Completed

Conditions: Obesity, Morbid

Treatments: Procedure: sleeve gastrectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT04228185

Banded_Sleeve

Details and patient eligibility

About

Weight regain after Laparoscopic Sleeve Gastrectomy (LSG) is nowadays a growing concern. Sleeve dilatation and loss of food restriction is considered the main mechanism. The placement of a silicon ring around the gastric tube seems to give benefits in the short-term.

The Investigators evaluate the efficacy of banded sleeve gastrectomy compared to standard sleeve in the mid-term.

Fifty patients were randomized between LSG and Laparoscopic Banded Sleeve Gastrectomy (LBSG), and they underwent a mean follow-up of 4 years.

Patients' management was exactly the same, apart from the band placement. After surgery differences in weight loss, operative time, complication rate and mortality were analyzed.

Enrollment: 50 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Morbid obesity
• Failure of medical treatment
• >18yrs; <60 yrs

Exclusion criteria

• Previous bariatric or GI surgery
• Psychiatric disease
• Pregnancy
• Contraindication to laparoscopy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Laparoscopic banded sleeve gastrectomy

Experimental group

Description:

Group undergoing banded sleeve

Treatment:

Procedure: sleeve gastrectomy

Laparoscopic sleeve gastrectomy

Active Comparator group

Description:

Group undergoing standard sleeve

Treatment:

Procedure: sleeve gastrectomy